Senator DOMINICK. Is it your concern, then, that if this national commission was put through as had been suggested by this resolution that the efforts in the private fields or in the semipublic fields would lessen? Dr. DUVAL. No. I would only be concerned about the one comment I made earlier that I would hope that, were such a Commission established, it would not be created in such a way as to relieve local groups, particularly those involved with scientists who are doing the work of the obligation and responsibility to continue to oversee what they are doing. Senator DOMINICK. I will pass on. Excuse me for taking so long. Senator KENNEDY. Just one final question. Doctor. On page 6, you mentioned that in 1971, the Department has again extended these guidelines to all grantees. Can you tell us who was involved in the development of those guidelines? Did you have philosophers and theologians and ethicists? Dr. MARSTON. Yes, Senator, we have required NIH not only at the national level-and I can give you the names of the advisers we used in setting them up-but also at the local level, that there be nonphysicians, lay representatives on the human representation committees, and in most instances, all that I know of, these have included clergymen as members of those commissions. Senator KENNEDY. I was interested, really, from the NIH point of view and how you developed your guidelines. Could you give me a note on that? Dr. MARSTON. Along that line, at our recent meeting on the ethical considerations in genetics, we did have about a third theologians, about a third scientists and about a third philosophers, generally. Senator KENNEDY. Yes. I would appreciate it if you could give me. a note on that: covering how you developed the guidelines and who participated in their development. Dr. MARSTON. We will be pleased to. (The information subsequently supplied follows:) ORIGINS OF THE DHEW POLICY ON PROTECTION OF HUMAN SUBJECTS 1. The Department's policy on protection of human subjects involved in activities supported by its grants and contracts is a direct lineal descendant of three prior Public Health Service issuances: b. a. Policy and Procedure Order No. 129, February 8, 1966 C. The Department's policy appeared as: d. Grants Administration Manual Chapter 1-40, April 15, 1971 (included on page of the hearings). 2. The development of the Public Health Service guidelines has been documented in considerable detail in an independent study carried out by the Program of Policy Studies in Science and Technology of the George Washington University by Mr. Mark Frankel. 3. The development of the Department of Health, Education, and Welfare policy from the Public Health Service policy is referred to only briefly in the above study and requires further description. Shortly after the release of "Protection of the Individual as a Research Subject," Under Secretary John G. Veneran distributed copies to all non-Public Health Service operating agencies within the Department, requesting that they move immediately to bring their operations into compliance with the policy. 2 This request met with immediate agreement in principle from all agencies, but with substantial reservation with regard to the language and applicability of the document, which was understandably strongly medical, and rather casual in its treatment of social and behavioral studies. A committee was set up under the chairmanship of Dr. Ernest M. Allen, Deputy Assistant Secretary for Grant Administration Policy in the office of the Assistant Secretary, Comptroller., The committee consisted largely of administrative staff who had been concerned with the administration of the Public Health Service policy, related programs in the Office of Education, or were familiar with the policy issues raised by the programs of the Social and Rehabilitation Service and the Social Security Administration. Staff support for the committee was provided by the Institutional Relations Section, Division of Research Grants, NIH. As the committee progressed with its work, the Institutional Relations Section initiated a series of meetings with grantee institutions to discuss the existing policy, to explore the feasibility of proposed modifications, and to gather suggestions. Meetings were held in association with the University of North Carolina-Duke University, University of Maryland, University of Minnesota, Rockefeller University, and Syracuse University. All major Public Health Service grantees in the vicinity of the meeting sites were asked to send at least two representatives; the chairman of the local institutional review committee established under the PHS policy, and at least one other institutional representative such as a responsible senior administrative officer, institutional legal counsel, or members of the institution's staff interested in the interfaces between scientific research, the law, philosophy and religion. Average attendance at each meeting was around 50-60 people. Among these contributing strongly to certain of these several meetings vore: Joseph H. Burchenal, M.D., Memorial Hospital Sloan-Kettering for L. P. Covington, L.L.B., North Carolina Department of Mental Sidney Dymond, L.L.B., Q. C.; University of Toronto, Canada 3 Renee C. Fox, Ph.D., University of Pennsylvania J. T. Hamill, III, M.D., University of Virginia Nash Herndon, Ph.D., Associate Dean, Bowman Gray School of Medicine Leslie Hicks, Ph.D., Howard University and American Psychological Association Sherman Kupfer, M.D., Associate Dean, Mount Sinai School of Medicine Irving Ladimer, S.J.D., Mount Sinai School of Medicine Mrs. Lorraine Lasker, A.B., New York Medical College Allen McCoyd, L.L.B., University of Minnesota School of Law David L. Segel, L.L.B., Associate Counsel, SUNY The predominance of medical and legal contributors is apparent. Minutes and full attendance lists for these meetings are available. As drafting continued, Dr. Ernest M. Allen circulated copies to representatives of the Deans' Committees of the American Association of Medical Colleges. Comments were received from approximately a fourth of the nations 83 dcans. Copies of various drafts were also made available to various private organizations including the American Civil Liberties Union, (Washington Chapter), the American Psychological Association, Committee on Responsible Government, and the Society for Health and Human Values. With the exception of the ACLU, direct response from this group was negligible. In its final stages the policy was reviewed by the Department's Grants Administration Advisory Committee, which includes representation of all of the Department's operating agencies, and of major types of private and public agencies involved in the receipt and administration of grants and contracts. The last review, prior to publication was provided by the Office of General Counsel, DHEW. As a result of their insistence, the informed consent requirements of the policy were substantially strengthened. 4 4. The "Institutional Guide to DEW Policy on the Protection of Major meetings were held in association with the, Massachusetts Among these contributing notably to this series of meetings were: Vernon Ahmadjian, Ph.D., Clark University Henry K. Beecher, M.D., Massachusetts General Hospital John Bowers, L.L.B., National Legal Program of Health Problems of the Poor William J. Curran, L.L.M., Harvard University Bernard L. Diamond, Ph.D., University of California, Berkeley Rosemary Ellis, R.N., Case Western Reserve University George Harwell, Dean, Pennsylvania State University School of Medicine Evelyn Hess, M.D., University of Cincinnati Allen Moore, Ph.D., Case Western Reserve Eli M. Nadel, M.D., St. Louis University Edwin B. Newnan, Ph.D., Harvard University Frederick Pitman, M.D., Medical College of South Carolina John M. Tyler, M.D., Lemuel Shattuch Hospital Lowell White, M.D., University of Florida In contrast with the meetings on the policy, this second group During the same period, staff were involved in other meetings in Florida Department of Health and Rehabilitation, Tallahassee, Florida Waltham, Massachusetts State University of New York, Potsdam, New York |